Cleared Traditional

K211291 - Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211291 · Fiagon GmbH · Ear, Nose, Throat device
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Jul 2021
Decision
82d
Days
Class 2
Risk

K211291 is an FDA 510(k) clearance for the Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation U.... Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on July 19, 2021 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.4560 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fiagon GmbH devices

Submission Details

510(k) Number K211291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2021
Decision Date July 19, 2021
Days to Decision 82 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 89d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGW Ear, Nose, And Throat Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Intended As An Aid For Precisely Locating A Surgical Instrument Within Anatomical Structures In Either Open Or Percutaneous Procedures For Any Medical Condition In Which A Reference To A Rigid Anatomical Structure In The Field Of Ent Surgery Can Be Identified Relative To A Ct- Or Mr-based Model Or Digitized Landmarks Of The Anatomy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - PGW Ear, Nose, And Throat Stereotaxic Instrument

All 35
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K211291.
Stealth AXiS™ ENT clinical application
K253395 · Medtronic Navigation, Inc. · Mar 2026
Navient Image Guided Navigation System (ENT) (955-NC-NC)
K243053 · Claronav · Jun 2025
TruDi® Navigation System V3 (FG-2000-00)
K231862 · Acclarent, Inc. · Jul 2023
ENT EM
K223734 · Brainlab AG · Apr 2023
TruDi Shaver Blade
K221037 · Acclarent, Inc. · Jul 2022
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
K221098 · Stryker Corporation · Jul 2022